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Medical Devices Evaluation Committee (MDEC)

The Medical Device Evaluation Committee (MDEC) provided independent medical and scientific advice to the Minister and the Therapeutic Goods Administration (TGA) on the safety, quality and performance of medical devices supplied in Australia including issues relating to premarket conformity assessment and post market monitoring.

MDEC was established under Regulation 35 of the Therapeutic Goods Regulations 1990. With the commencement of Australia's new regulatory framework for medical devices on 4 October 2002, MDEC replaced the previous statutory expert committee, the Therapeutic Device Evaluation Committee (TDEC).